Surgical Site InfectionTWISTNCT02704897
Tracking Wound Infection With Smartphone Technology
A study testing Wound Assessment Tool in people with Surgical Site Infection, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
This study aims to evaluate if a smartphone-delivered tool can help assess for wound infections, and if this improves access to care and results in earlier treatment. Participants will be randomised to one of two groups. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Wound Assessment Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Jun 2016to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Emergency Abdominal Surgery Patients
- Smartphone Owners
- Able to give valid consent
Who cannot join
- Significant visual impairment
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Infirmary Edinburgh
Edinburgh, EH16 4SA
Western General Hospital
Edinburgh, EH4 2XU
About this study
Official title: Can a Smartphone-delivered Tool Facilitate the Assessment of Surgical Site Infection, and Result in Earlier Treatment? A Randomized-controlled Trial in Emergency Surgery Patients.
This study aims to evaluate if a smartphone-delivered tool can help assess for wound infections, and if this improves access to care and results in earlier treatment. Participants will be randomised to one of two groups. The intervention group will receive the smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about their wound. The trial period is 30 days.
Read the detailed description
Surgical site infection (SSI) is defined by the Centre for Disease Control and Prevention (CDC) as an infection in the skin and soft tissues of a surgical wound, within 30 days of the operation. It is a common problem, and complicates 2-10% of general surgery operations. The majority of cases are diagnosed outside of hospital and can be treated with oral antibiotics.
Interest in the use of technology in medicine is increasing, with the potential that more advanced technology will help facilitate communication between clinicians and patients, aid in the assessment of patients, and improve clinical decision making. Over two-thirds of people now own smartphones, and regularly use them to access the internet. The investigators wish to use a smartphone delivered questionnaire to help assess SSI and see if this improves access to care and time to treatment.
The investigators will be recruiting emergency surgery patients with smartphones at the Royal Infirmary and Western General Hospitals in Edinburgh.
Participants will be divided into two groups. One group will receive the wound assessment tool, if they are concerned about their wound, they can use the tool to answer a series of questions. If their answers suggest SSI, a clinician will contact them to advise further assessment and treatment. The participants will also be asked to respond to the tool three times during the trial (to collect responses from those without symptoms), and upload photos of their wounds to a secure database.
The second group of participants will receive normal post-operative care.
After 30 days, participants will have a follow-up consultation, to determine if they have had a wound infection (this can be via telephone or face-to-face, according to participant preference). They will also answer questions about their experience of the study, and use of services.
- Conditions
- Surgical Site Infection
- Being tested
- Wound Assessment Tool
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound Assessment ToolOther
A set of questions relating to the symptoms of wound infection
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Wound assessment tool - delivered via a smartphone. A link will be sent to participants on discharge, which can be accessed at any point should they have concerns about their wound.
They will also be sent the tool at 3 additional time-points. Receives: Other: Wound Assessment Tool |
| Control Arm | No intervention | Normal Post-operative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from surgery to treatment for surgical site infection
Measured in days from surgery to commencing antibiotic treatment
Measured: Outcome assessed at 30 day follow-up
Secondary outcomes (2)
Service Usage
Number of attendances at General Practice (GP) and Accident and Emergency (A\&E).
Measured: Assessed at 30 day follow-up
Access to Services
How long in days between experiencing first symptom and being reviewed by A\&E, GP or surgical team
Measured: Assessed at 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start14 Jun 2016
- Primary completion20 Oct 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewen Harrison, BM CHB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704897
- Sponsor's protocol ID
- AC16032
- Acronym
- TWIST
- Status last verified
- May 2024
- First submitted
- 2 Mar 2016
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McLean KA, Mountain KE, Shaw CA, Drake TM, Ots R, Knight SR, Fairfield CJ, Sgro A, Skipworth RJE, Wigmore SJ, Potter MA, Harrison EM. Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients. BMJ Open. 2019 Oct 3;9(10):e029620. doi: 10.1136/bmjopen-2019-029620.
PubMed 31585971
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Smartphone-delivered Tool Facilitate the Assessment of Surgical Site Infection, and Result in Earlier Treatment? A Randomized-controlled Trial in Emergency Surgery Patients.
- ClinicalTrials.gov ID
- NCT02704897
- Acronym / sponsor ID
- TWIST / AC16032
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate if a smartphone-delivered tool can help assess for wound infections, and if this improves access to care and results in earlier treatment. Participants will be randomised to one of two groups. The intervention group will receive the smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about their wound. The trial period is 30 days.
Detailed description
Surgical site infection (SSI) is defined by the Centre for Disease Control and Prevention (CDC) as an infection in the skin and soft tissues of a surgical wound, within 30 days of the operation. It is a common problem, and complicates 2-10% of general surgery operations. The majority of cases are diagnosed outside of hospital and can be treated with oral antibiotics.
Interest in the use of technology in medicine is increasing, with the potential that more advanced technology will help facilitate communication between clinicians and patients, aid in the assessment of patients, and improve clinical decision making. Over two-thirds of people now own smartphones, and regularly use them to access the internet. The investigators wish to use a smartphone delivered questionnaire to help assess SSI and see if this improves access to care and time to treatment.
The investigators will be recruiting emergency surgery patients with smartphones at the Royal Infirmary and Western General Hospitals in Edinburgh.
Participants will be divided into two groups. One group will receive the wound assessment tool, if they are concerned about their wound, they can use the tool to answer a series of questions. If their answers suggest SSI, a clinician will contact them to advise further assessment and treatment. The participants will also be asked to respond to the tool three times during the trial (to collect responses from those without symptoms), and upload photos of their wounds to a secure database.
The second group of participants will receive normal post-operative care.
After 30 days, participants will have a follow-up consultation, to determine if they have had a wound infection (this can be via telephone or face-to-face, according to participant preference). They will also answer questions about their experience of the study, and use of services.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Wound Assessment ToolWound assessment tool - delivered via a smartphone. A link will be sent to participants on discharge, which can be accessed at any point should they have concerns about their wound. They will also be sent the tool at 3 additional time-points. |
| Control Arm | No intervention | –Normal Post-operative Care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency Abdominal Surgery Patients
- Smartphone Owners
- Able to give valid consent
Key exclusion criteria (1 listed)
- Significant visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound Assessment ToolA set of questions relating to the symptoms of wound infection | Other | Intervention Arm |
Primary outcome
Time from surgery to treatment for surgical site infection
Time frame: Outcome assessed at 30 day follow-up
Measured in days from surgery to commencing antibiotic treatment
2 secondary outcomes
Service Usage
Time frame: Assessed at 30 day follow-up
Access to Services
Time frame: Assessed at 30 day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 31585971McLean KA, Mountain KE, Shaw CA, Drake TM, Ots R, Knight SR, Fairfield CJ, Sgro A, Skipworth RJE, Wigmore SJ, Potter MA, Harrison EM. Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients. BMJ Open. 2019 Oct 3;9(10):e029620. doi: 10.1136/bmjopen-2019-029620.
- Public Health England. Surgical site infection surveillance service (SSISS). (2014).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewen Harrison, BM CHB principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Assessment Tool in people with Surgical Site Infection, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from surgery to treatment for surgical site infection (time frame: Outcome assessed at 30 day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.